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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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Alpine BioMed - 05704736001847

KEYPOINT WS SPXP-OS
Alpine Biomed ApS
9031A006504
Not in Commercial Distribution

  • 05704736001847 ()


  • Electromyograph

Alpine BioMed - 00681490920650

2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0501
Not in Commercial Distribution

  • 00681490920650 ()


  • Electromyograph

Alpine BioMed - 00681490508865

4 CH. AMP.BOX/ARM, KEYPOINT
Alpine Biomed ApS
9031C0311
Not in Commercial Distribution

  • 00681490508865 ()


  • Electromyograph

Alpine BioMed - 00681490853149

4 CH EP ADC BOARD FOR KEYPOINT
Alpine Biomed ApS
9031C5623
Not in Commercial Distribution

  • 00681490853149 ()


  • Electromyograph

Focus - 04650075330074

2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.
NEUROSOFT, OOO
Focus
In Commercial Distribution

  • 04650075330074 ()


  • Electromyograph

SX230FW EMG Sensor - 05060481691512

The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230FW
In Commercial Distribution

  • 05060481691512 ()
bandwidth 20-460 metal connector

  • Electromyograph

SX230-100 EMG Sensor - 05060481691505

The SX230-100 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-100 EMG Sensor (Gain 100, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-100
In Commercial Distribution

  • 05060481691505 ()
Gain 100, bandwidth 20-460 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691499

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-1000Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691499 ()
bandwidth 5-1000 metalconnector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691482

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm..This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. SX230-1000 EMG Sensor (Gain 1000, Bandwidth 5-480Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691482 ()
bandwidth 5-480 metal connector

  • Electromyograph

SX230-1000 EMG Sensor - 05060481691475

The SX230-1000 EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. Biometrics Ltd precision bipolar, differential EMG sensors have integral electrodes with a fixed electrode distance of 20mm. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 SX230-1000 EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Metal connector
BIOMETRICS LIMITED
SX230-1000
In Commercial Distribution

  • 05060481691475 ()
bandwidth 20-460 metal connector

  • Electromyograph
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